ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2547

Weekly Subcutaneous Abatacept Confers Comparable Onset of Treatment Response and Magnitude of Efficacy Improvement Over 6 Months When Administered with or without an Intravenous Abatacept Loading Dose

M. Schiff1, R. Alten2, M. Weinblatt3, P. Nash4, Roy Fleischmann5, P. Durez6, J. Kaine7, I. Delaet8, S. Kelly8, M. Maldonado8, S. Patel8 and M. C. Genovese9, 1University of Colorado, Denver, CO, 2Schlosspark-Klinik, University Medicine, Berlin, Germany, 3Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, 4University of Queensland, Brisbane, Australia, 5University of Texas Southwestern Medical Center, Dallas, TX, 6Université Catholique de Louvain, Brussels, Belgium, 7Sarasota Arthritis Research Center, Sarasota, FL, 8Bristol-Myers Squibb, Princeton, NJ, 9Stanford University, Palo Alto, CA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Efficacy of Approved Biologics

Session Type: Abstract Submissions (ACR)

Background/Purpose: To compare clinical and functional responses with SC abatacept administered with or without an IV loading dose, in pts with active RA and inadequate response to methotrexate (MTX). Methods: Pts from the intent-to-treat (ITT) populations of the ACQUIRE1 and AMPLE2 studies randomized to SC abatacept plus MTX were included in this analysis. All pts received fixed-dose SC abatacept 125 mg/week; in ACQUIRE, pts also received an IV loading dose (~10 mg/kg based on weight range) on Day 1; no IV loading dose was administered in AMPLE. For this post-hoc analysis, assessments included ACR 20 and Health Assessment Questionnaire-Disability Index (HAQ-DI) response (improvement of ≥0.3) over 6 months, with pts who discontinued considered non-responders. Mean changes from baseline over 6 months in Disease Activity Score (DAS) 28 (C-reactive protein; CRP) were assessed in pts with DAS28 >5.1 at baseline (last observation carried forward), to account for differences in baseline disease activity between the two studies. Results: A total of 736 pts from ACQUIRE (IV loading dose) and 318 pts from AMPLE (no IV loading dose) were included. All pts were biologic-naïve at baseline, with mean disease duration of 7.6 and 1.8 years, DAS28 (CRP) 6.2 and 5.5, and HAQ-DI 1.72 and 1.5 in ACQUIRE and AMPLE, respectively. Efficacy was compared at Days 15, 29, 57, 85, 113, 141 and 169. For pts treated with SC abatacept with an IV loading dose, ACR 20 response rates were 24.6, 44.5, 58.0, 66.6, 69.3, 72.4 and 74.8%, respectively. For pts treated without an IV loading dose, ACR 20 response rates were similar: 27.4, 42.5, 58.5, 60.1, 66.0, 70.1 and 66.0%, respectively. HAQ-DI response rates were also similar: 31.7, 45.1, 53.5, 59.5, 63.2, 64.4 and 68.3%, respectively, with the IV loading dose, and 31.8, 42.8, 54.4, 58.5, 60.1, 61.9 and 61.0%, respectively, without. For the overall populations, mean (SD) changes from baseline to Day 169 in DAS28 were –2.57 (1.30) and –2.09 (1.38) in ACQUIRE and AMPLE, respectively. For pts with baseline DAS28 >5.1, mean changes in DAS28 over time were also comparable for both studies (Figure).

Conclusion: Time to onset and magnitude of ACR 20 and HAQ-DI responses and DAS28 improvements were similar for pts treated with SC abatacept with or without IV loading in patients with RA and an inadequate response to MTX. Previous pharmacokinetic data show that in the absence of IV loading, target therapeutic concentrations are achieved in the majority of pts by Week 2 of SC abatacept treatment.3 The findings from this post-hoc analysis suggest that SC abatacept can be given effectively without an IV abatacept loading dose.                                                                                         1. Genovese MC, et al. Arthritis Rheum 2011;63(10):2854-64 2. Schiff M, et al. Ann Rheum Dis 2012;71(Suppl 3):60        3. Murthy B, et al. Ann Rheum Dis 2011;70(Suppl 3):459   Figure (3).jpg 

Disclosure:

M. Schiff,

Bristol-Myers Squibb,

5,

Abbott Immunology Pharmaceuticals,

8;

R. Alten,

ABBOTT, BMS, GSK,NOVARTIS, PFIZER, UCB,

2;

M. Weinblatt,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5;

P. Nash,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5,

Bristol-Myers Squibb,

8;

R. Fleischmann,

Genentech Inc., Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, Astra-Zeneca, Jansen,

2,

Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, Novartis, Astellas, Astra-Zeneca, Jansen, HGS,

5;

P. Durez,

BMS – Less than US$2000 ,

8;

J. Kaine,

Bristol-Myers Squibb,

5,

Bristol-Myers Squibb,

8;

I. Delaet,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

S. Kelly,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

M. Maldonado,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

S. Patel,

Bristol-Myers Squibb,

3;

M. C. Genovese,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5.

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